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Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

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NCT00743652

Last updated on December 5, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Akiak, Alaska, 99552 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease, 13-valent Pneumococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42 + days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female infants 6 weeks to entire study period and reachable by phone, parents able to complete all relevant
study procedures.

- Infants who have received Prevnar are eligible to participate, but this is not
required.

- Infants participating in the blood draws must live in a specific identified area
(Yukon Kuskokwim Delta region)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any
vaccines or vaccine related components, immune deficiency, bleeding disorder or major
known congenital malformation.

NCT00743652
Pfizer
Completed
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Official Title  ICMJE A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
Brief SummaryThis study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumococcal Disease
  • 13-valent Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Study Arms  ICMJE
  • Experimental: Group1
    Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 2
    Subjects <12 months of age with 1 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 3
    Subjects <12 months of age with 2 prior doses of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 4
    Subjects ?12 months to <2 years of age.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 5
    Subjects ?2 years to <5 years of age
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)		373
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)		2500
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateSeptember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
  • Infants who have received Prevnar are eligible to participate, but this is not required.
  • Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

  • Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743652
Other Study ID Numbers  ICMJE 6096A1-3010
B1851009
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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